NCT04118088

A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula

Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal Fistula

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim is to check the long term side effects of a repeat treatment of darvadstrocel and to see if that treatment improves symptoms of Crohn's disease and complex perianal fistula. Participants will attend 8 clinic visits and will receive 1 treatment of darvadstrocel at the third visit. A magnetic resonance imaging (MRI) will be performed several times during the study.

Detailed description

The biological being tested in this study is called darvadstrocel (Alofisel). This study is examining the long-term safety and efficacy of a repeat dose of darvadstrocel in people who have Crohn's disease and complex perianal fistula. The study will enroll approximately 50 patients. Participants will be assigned to one treatment group to receive: • Darvadstrocel 120 million cells All participants would be allowed to receive one repeat dose of darvadstrocel in the whole study. This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 3 years. Participants will make multiple visits to the clinic.

Conditions

• Crohn's Disease
• Complex Perianal Fistula

Interventions

Type	Name	Description
BIOLOGICAL	Darvadstrocel	Darvadstrocel suspension of human expanded adipose stem cells.

Timeline

• Start date: 2020-12-22
• Primary completion: 2025-02-14
• Completion: 2025-02-14
• First posted: 2019-10-08
• Last updated: 2026-01-22
• Results posted: 2026-01-22

Locations

30 sites across 6 countries: Austria, Czechia, France, Germany, Israel, Spain

Regulatory

• FDA-regulated drug study